EUCTR2019-000922-23-DE进行中（未招募）1 期
Transarterial chemoembolization (TACE) with Irinotecan and Mitomycin C versus TACE with Doxorubicin in patients with Hepatocellular carcinoma not amenable to curative treatment - IRITACE- a randomized multicenter phase 2 trial. A trial of the German Alliance for Liver Cancer (GALC) - TACE with Irinotecan and Mitomycin C in HCC
Goethe-Universität Frankfurt0 个研究点目标入组 104 人开始时间: 2020年1月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent granted prior to initiation of any study specific screening procedures
- •2. Patients with histologically confirmed HCC primarily not suitable for resection, ablation or liver transplantation. A combined therapy with TACE and subsequent ablation is possible.
- •3. Availability of Biopsy for translational research, if patients give their consent
- •4. Absence of extrahepatic spread
- •5. Age >/= 18 years
- •6. Patients with measurable disease according to mRECIST
- •7. Performance status ECOG 0 and 1 (Appendix 20)
- •8. Normal organ and bone marrow function defined as:
- •– Hematopoetic: absolute neutrophil count = 1,500/mm3, platelet count = 60 x 109/l, hemoglobin = 9 g/dL
- •– INR = 1.5 x ULN
- •– Hepatic: AST and ALT < 5 x ULN, bilirubin = 2 mg/dl
- •– Renal: serum creatinine = 1.5 x ULN
- •9. Child-Pugh stage A
- •10. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolment
- •11. Male or female patients of child-bearing potential must agree to use oral contraception, intrauterine device, bilateral tubal occlusion, vasectomized partner or avoidance of intercourse during the study and for 180 days after last investigational drug dose received
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •1. Extrahepatic tumor manifestation
- •2. Tumor infiltration of more than 50% of the whole liver mass
- •3. Infiltration or thrombosis of the main portal vein or the main left or right intrahepatic branches
- •4. Child Pugh status B or C > 6 points according to Child Pugh classification (Appendix 20)
- •5. Prior TACE or selective intraarterial Radiotherapy (SIRT)
- •6. Prior systemic anticancer therapy for HCC
- •7. Life expectancy of less than 12 weeks
- •8. Esophageal varices grade III (any) or esophageal varices grade II with increased risk for bleeding (red wale signs, cherry spots, red coloration, hematocystic spots) without prophylactic band ligation
- •9. Known or suspected manifest hyperthyroidism
- •10. Congestive heart failure > class II NYHA (Appendix 20)
- •11. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy, acute myocardial infarction, myocardial infarction, acute inflammatory heart disease > CTCAE grade 2 within the past 6 months (Appendix 20)
- •12. Previous treatment with doxorubicin up to the maximum lifetime dose of 550mg/m2
- •13. History of organ allograft or bone marrow transplantation
- •14. Active uncontrolled clinically serious infections > CTCAE grade 2 except chronic hepatitis C infection (Appendix 20)
- •15. Severe restrictive or obstructive lung disease
- •16. Clinically apparent chronic inflammatory bowel disease and/or ileus
- •17. Hemorrhage/bleeding event or variceal bleeding > CTCAE grade 2 within 4 weeks of first dose of study drug (Appendix 20)
- •18. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
- •19. Known or suspected allergies to Iodine-containing or Gadolinum-containing contrast medium, Irinotecan, Mitomycin C, Doxorubicin or other inactive ingredients of the drugs
- •20. Previous cancer that is distinct in primary site or histology from HCC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry
- •21. Concomitant treatment with St. John's wort
- •22. Substance abuse, medical, psychological or social condition that may interfere with the patient´s participation in the study
- •23. Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment
- •24. Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)
- •25. Pregnancy or breast-feeding women
研究者
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